You can tell from the many TV, radio and online advertisements that supplement purchases are on the rise. While I am firmly in the camp that believes we should get our nutrients from whole foods, I recognize that supplements can greatly assist in one’s journey to better health.
However, I know from my conversations with clients that most people have no idea the importance of evaluating and choosing high-quality supplement brands.
Why Supplement Quality Matters
When it comes to dietary supplements, quality – or the inherent characteristic – matters. Case in point: You may have seen or heard about the warning letter the Food and Drug Administration (FDA) sent to Amazon in December 2023. This letter centered on ingredients found in several supplements formulated for men. According to the letter, “laboratory analyses confirmed that they contained undeclared and potentially harmful active pharmaceutical ingredients.”
These ingredients, sildenafil and tadalafil, are active ingredients found in FDA-approved drugs, like Viagra and Cialis, to treat erectile dysfunction (ED). However, these same ingredients may dangerously lower blood pressure if combined with some prescription drugs. These ingredients aren’t “bad” per se, but the issue lies in that the ingredients were not included on the product labels, potentially harming hundreds and/or thousands of trusting, yet unknowing, users.
A literature review published in April 2022 combed through 50 studies to investigate the “presence of undeclared compounds” in supplements used by professional athletes. In order to compete, professional athletes must avoid many banned substances specified by the World Anti-Doping Agency. The review concluded that “more than 28% of the analyzed dietary supplements pose a potential risk of unintended doping.” The authors strongly warned athletes and trainers to be careful when consuming dietary supplements.
And, in 2013, researchers at the Canadian University of Guelph published the results of a blind test they conducted to confirm that herbal products contain the ingredients claimed on the labels. They tested 44 products from 12 different companies located in Canada and the U.S. In order to identify the herbs in each product, the researchers used DNA barcoding, which can identify a species based on the DNA of a tissue sample.
What did they find, but that 33% of the products did not actually contain the main herb listed on the label. That’s one out of 3 products! And nearly 60% of the products included plant material that was NOT listed on the labels. The researchers concluded that “…most of the herbal products tested were of poor quality, including considerable product substitution, contamination and use of fillers.” So, yes, it’s important to choose high-quality supplement brands.
How Does Supplement Regulation Work?
When it comes to regulating dietary supplements, who is in charge? Technically, it’s the Food and Drug Administration (FDA). In 1994, the Dietary Supplement Health Education Act (DSHEA) was passed, giving the FDA the responsibility to regulate supplements produced in the U.S. as well as supplements produced in other countries and sold in the U.S. Sounds good, but how are these products regulated?
Right upfront, the FDA states it is not allowed to review supplements for safety and effectiveness BEFORE they go to market. Instead, the FDA reviews labels for misbranded claims and/or harmful ingredients after products are available to the public. If the FDA finds fault with a product, both manufacturers and distributors can be held responsible and/or the FDA can pass additional regulations. For example, in 1997, the FDA required label warnings for supplements with added iron after several children died from accidental overdoses.
The Consumer Healthcare Products Association (CHPA), based in Washington, D.C., is a third-party organization that is “fighting to ensure that Americans have access to over-the-counter (OTC) medications, dietary supplements, and consumer medical devices they can count on to be reliable, save money and time, and deliver new and better ways to get and stay healthy (emphasis mine).” According to a 2022 press release, CHPA has called for an overhaul of the 1994 DSHEA after the Journal of the American Medical Association (JAMA) claimed that 29% of products that received warning letters from the FDA remained on the marketplace.
While JAMA acknowledged that the study had a limited sample size, it brought to light the problems the FDA has to confirm that manufacturers comply with its warning letters.
What is Considered a Dietary Supplement?
According to the FDA, dietary supplements are products “intended to add to or supplement the diet,” but they are not food. Some examples are:
- Vitamins
- Minerals
- Herbs/botanicals
- Amino acids
- Probiotics or “live microbials”
Dietary supplements can be packaged as tablets and capsules but can also take the form of gummies and liquids.
Are Expensive Supplements Better?
There is conflicting advice by practitioners on how best to choose supplement products. According to Dr. Mark Moyad, author of The Supplement Handbook, “…some of the least expensive products work almost as well as, and sometimes better than, the most expensive ones.” Therefore, price may not be a guarantee of quality and effectiveness.
However, Dr. Moyad cautions to make sure a supplement contains the active ingredient(s) it claims and isn’t full of contaminated materials. So where do consumers begin to evaluate supplement brands?
How To Know if a Supplement is Third-Party Tested
When the FDA confirms the identity, ensures the purity, and evaluates the quality of a supplement, it does so via The Dietary Supplement Current Good Manufacturing Practice (DSCGMP). Under the term “quality,” the manufacturer must consistently meet the established specifications for identity, purity, strength and composition. Contaminants are limited and manufacturers must present their products to the marketplace in such a way as to prevent adulteration. In other words, the manufacturers’ own quality and control departments must verify that product specifications are met through several criteria, including:
- Employee training
- Manufacturing design
- Quality control procedures
- Facility sanitation and climate, and
- Written records of product complaints
The Good Manufacturing Practices (GMP) certified label is a great start to help consumers identify manufacturers who comply with FDA regulations. For supplements targeted to athletes, there is a GMP Certified for Sport label that confirms no banned substances are included in the product’s ingredients.
In addition to the DSCGMP, manufacturers can proactively submit their products for third-party certification. While these third-party supplement tests do not guarantee the safety or effectiveness, it does show that these manufacturers have gone the extra mile to have their products meet industry guidelines for identity, quality and potency. Some of these organizations are:
- NSF International – NSF claims that its certification demonstrates the product meets their stringent standard requirements. The NSF website has a search tool that consumers can use to locate details of a specific company or product, including dietary supplements.
- Natural Products Association – The NPA is a trade association for dietary supplements, natural health & sports nutrition, medical & functional foods, probiotics, and natural personal/home care products. It offers several certifications for the products they test, including their TruLabel certification for dietary supplements.
- US Pharmacopeia – According to the organization’s website, the USP is an independent scientific organization. Its certification “signals to the public that what’s on their label is what’s in the bottle.”
- ConsumerLab.com – This group claims to be the leading provider of independent test results and information to “help consumers and healthcare professionals identify the best quality health and nutrition products.” Information is available to consumers as a subscription. One very nice benefit ConsumerLab.com offers is an up-to-date section of product recalls and warnings.
Again, these certifications are important in that the manufacturers spend significant cost, time, documentation, facility checks and other resources to receive the certification(s), but this is still no guarantee of a supplement’s safety and efficacy.
How to Evaluate Supplement Labels
High-quality supplement brands will clearly list the ingredients contained in their products on the Supplement Facts Label. This area of packaging lists all contents in the supplement, including any added ingredients not listed on the front of the label such as fillers, binders and flavorings.
In general, I recommend to my clients to be wary of ingredients they cannot pronounce and, as much as possible, do not buy products that list “natural” flavorings – a very ambiguous term as no one knows what “natural” tastes like!
The Future of Supplement Quality Regulation is Coming – Maybe?
In January 2024, the bipartisan Congressional Dietary Supplement Caucus reconvened with a mission to
“… discuss…the benefits of dietary supplements, provide tips and insights for better health and wellness, and to promote research into the health care savings these products provide.”
Five industry trade associations supported the caucus’ efforts through a joint press release, including the:
- American Herbal Products Assoc. (AHPA)
- Consumer Healthcare Products Association (CHPA)
- Council for Responsible Nutrition (CRN)
- Natural Products Association (NPA) and
- United Natural Products Alliance (UNPA)
According to the press release, the caucus “seeks to enhance congressional attention to the role of supplements in promotion, disease prevention and address the regulation of the supplement industry.” Speculation on the issues the caucus may consider include reforming DSHEA and providing funding for additional FDA oversight. If the caucus takes its role seriously and stays siloed from too much industry influence, this could be a good sign for consumers.
What Supplement Brand Should I Take?
At the end of the day, I believe that the body knows how to handle nutrients from whole foods, and I will always recommend a whole food diet over supplementation. The more robust and less processed your nutrient intake is, the better your chances are of not needing dietary supplementation. However, in many circumstances such as pregnancy, disease, and aging, high-quality supplementation can offer a big advantage to a healthy diet.
Whether you choose to supplement at the recommendation of a medical practitioner or of your own volution, researching brands is key.
- Look for third-party certifications on labels to identify manufacturers who have gone the extra mile to validate their processes and ingredients.
- Do a Google search to see if a brand has had any product recalls.
- Search product reviews to identify any potential supplement pitfalls.
- Finally, always start “low and slow” with any new supplement; that is, start at the lowest dose for several days and then, if you notice no side effects, gradually increase to the desired dosage. At the first sign of any negative effects, return to the previous dosage or discontinue and consult your medical practitioner for advice.
As the saying goes, you can’t supplement your way out of a poor diet! Remember that dietary supplements do just that – supplement – they do not replace a healthy diet.
